MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2C6250
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3/d10: the event began around september 15th, 2025.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the packaging of an unspecified quantity of dual luer lock caps were challenging to open.Scissors were used to try to rip the packaging resulting in many caps landing on the floor or being contaminated.The issue was further described as "the edges provide no lose edge for staff to be able to tear away the clear packaging from the white backing".There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: d4: expiration date (update the null value to n/a), h6 (update codes), and h11.H11: the actual devices were not available; however, photographs of the samples and nine (9) companion samples were received for evaluation.A visual inspection was performed on all the samples.Photos 1 and 2 showed the back of the blister packaging, while photo 3 displayed the front (printed side) of one (1) blister package related to the product.The visual inspection of the companion samples did not identify any abnormalities that could have contributed to the reported condition.A functional test was performed and the blister packaging was difficult to open, the test failed in eight (8) samples.The reported condition was not observed in one (1) unit.The reported condition was verified in eight (8) companion samples.The cause of the issue was related to manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NA
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd. 721, km. 0.3; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23404766
• Report Number: 1416980-2025-05304
• Device Sequence Number: 11990958
• Product Code: FPA
• UDI-Device Identifier: 00085412036311
• UDI-Public: (01)00085412036311(10)12301
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 2C6250
• Device Catalogue Number: 2C6250
• Device Lot Number: 12301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown